According to the FDA, counterfeit pharmaceutical drugs pose a significant threat to the public safety and to the integrity of the overall drug supply chain. Drug counterfeiting has increased in recent years, which is potentially related to the increased number of access points that exist in the supply chain for many of these drugs. Prescription pharmaceutical drugs are typically transferred between a number of different parties before they are eventually dispensed to a consumer. For example, a drug may be produced by a manufacturer, then handed off to a distributor, and then delivered to a pharmacy or other retailer before finally being dispensed to a consumer. With each of these transfers, and with every additional handler of the drugs, there is an inherent risk of potential foul play.
In an attempt to prevent or at least minimize drug counterfeiting and other improper drug transfers, many federal and state government agencies now require, or may soon require, that records of these drug transfers be tracked and maintained—essentially creating a chain of custody for the drug from the time it is produced until it reaches the consumer. This chain of custody information is often referred to as the pedigree of a drug, and it was traditionally maintained via inefficient paper documentation. Paper-based drug pedigrees allowed agencies to more efficiently track and prosecute counterfeiting activities, but did little to prevent such activities due to intrinsic delays associated with a paper-based system. More recently, the pedigree information is increasingly being stored in electronic form. These electronic records are often referred to as the electronic pedigree, or e-pedigree, of a drug.